| CTRI Number |
CTRI/2023/04/051431 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Status of digestion in non alcoholic fatty liver disease and the therapeutic effect of chitrakapippali ghrita. |
|
Scientific Title of Study
|
An observational study to assess the status of agni in yakrita vikara (nafld) and the upashayatmak effect of chitrakapippali ghrita- single arm open label study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Meena |
| Designation |
Pg scholar |
| Affiliation |
AII India Institute of Ayurveda |
| Address |
Department of roga nidan evum vikriti vigya, 3rd floor, administrative block, All India Institute of Ayurveda, New Delhi
Gautam puri, sarita vihar ,mathura road, new delhi-110076
South
DELHI
110076
India |
| Phone |
9560138479 |
| Fax |
|
| Email |
rashmisweet835@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Meena |
| Designation |
PG Scholar |
| Affiliation |
AII India Institute of Ayurveda |
| Address |
Department of roga nidan evum vikriti vigyan, 3rd floor, administrative block, All India Institute of Ayurveda, New Delhi
Gautam puri, sarita vihar, mathura road, new delhi-110076
South
DELHI
110076
India |
| Phone |
9560138479 |
| Fax |
|
| Email |
rashmisweet835@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh Tiwari |
| Designation |
Associate professor |
| Affiliation |
AII India Institute of Ayurveda |
| Address |
Department of roga nidan evum vikriti vigyan, 3rd floor, administrative block, All India Institute of Ayurveda, New Delhi
Gautam puri, sarita vihar, mathura road, new delhi-110076
South
DELHI
110076
India |
| Phone |
7276256248 |
| Fax |
|
| Email |
stiwari423@gmail.com |
|
|
Source of Monetary or Material Support
|
| AII INDIA INSTITUTE OF AYURVEDA |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA
GAUTAMPURI, SARITA VIHAR, NEW DELHI-110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashmi Meena |
O.P.D room no. 1 and IPD of All India Institute of Ayurveda |
Department of roga nidan evum vikriti vigyan, All India Institute of Ayurveda,sarita vihar, New Delhi-110076
South
DELHI |
9560138479
rashmisweet835@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: CHITRAKAPIPPALI GHRITA, Reference: BHAISHAJYA RARNAVALI, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
GRADE I and II NAFLD |
|
| ExclusionCriteria |
| Details |
Patients suffering from diabetic Mellitus, dyslipidemia, hypothyroidism, IBS, joint disorders, CAD, TB, and carcinoma
Patients having Grade III NAFLD and any other liver disease
Patients on medication for non-alcoholic fatty liver disease during last 3 months.
Lactating and pregnant women. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Status of agni as assessed through CCRAS agni assessment questionnaire. |
Status of agni will be assessed at 1st,15th,30th,46th day of intervention. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in USG finding. |
Changes in USG findings will be assessed at 1st and 46th day. |
|
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Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/06/2023 |
| Date of Study Completion (India) |
15/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION Ayurveda has described agni as an important factor of digestion and metabolism in our body. It acts as an invariable agent in the process of paka and includes the complete process of ingestion and transformation. In our classical Ayurvedic texts agni varies and is classified according to the pakriti, dosha, dhatu, and the function.
RESEARCH QUESTION - What is the role of status of agni in yakrita vikara (NAFLD)? - What is the clinical efficacy of chitrakapippali ghrita in yakrita vikara (NAFLD) patients?
HYPOTHESIS: Null Hypothesis: - The agni does not have any significant role in the pathogenesis of yakrita vikara (NAFLD). - The administration of chitrakapippali ghrita does not have any beneficial clinical effect in yakrita vikara (NAFLD) patients. Alternate Hypothesis: - The agni plays a significant role in the pathogenesis of yakrita vikara (NAFLD). - The administration of chitrakapippali ghrita has significant beneficial clinical effect in yakrita vikara (NAFLD) patients.
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